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SEGLUROMET Drug Patent Profile

Which patents cover Segluromet, and what generic alternatives are available?

Segluromet is a drug marketed by Msd Sub Merck and is included in one NDA. There are three patents protecting this drug.

This drug has eighty-six patent family members in forty-nine countries.

The generic ingredient in SEGLUROMET is ertugliflozin; metformin hydrochloride. One supplier is listed for this compound. Additional details are available on the ertugliflozin; metformin hydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Segluromet

Segluromet was eligible for patent challenges on December 19, 2021.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 21, 2030. This may change due to patent challenges or generic licensing.

There have been three patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for SEGLUROMET

International Patents:	86
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Drug Prices:	Drug price information for SEGLUROMET
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SEGLUROMET
What excipients (inactive ingredients) are in SEGLUROMET?	SEGLUROMET excipients list
DailyMed Link:	SEGLUROMET at DailyMed

See drug prices for SEGLUROMET

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for SEGLUROMET

NDA:

209806

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for SEGLUROMET

Drug Class

Biguanide

US Patents and Regulatory Information for SEGLUROMET

SEGLUROMET is protected by three US patents and one FDA Regulatory Exclusivity.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Msd Sub Merck	SEGLUROMET	ertugliflozin; metformin hydrochloride	TABLET;ORAL	209806-002	Dec 19, 2017		RX	Yes	No
Msd Sub Merck	SEGLUROMET	ertugliflozin; metformin hydrochloride	TABLET;ORAL	209806-001	Dec 19, 2017		RX	Yes	No			Y
Msd Sub Merck	SEGLUROMET	ertugliflozin; metformin hydrochloride	TABLET;ORAL	209806-002	Dec 19, 2017		RX	Yes	No

EU/EMA Drug Approvals for SEGLUROMET

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Merck Sharp & Dohme B.V.	Segluromet	ertugliflozin, metformin hydrochloride	EMEA/H/C/004314 Segluromet is indicated in adults aged 18 years and older with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control:in patients not adequately controlled on their maximally tolerated dose of metformin alonein patients on their maximally tolerated doses of metformin in addition to other medicinal products for the treatment of diabetesin patients already being treated with the combination of ertugliflozin and metformin as separate tablets.	Authorised	no	no	no	2018-03-23

International Patents for SEGLUROMET

When does loss-of-exclusivity occur for SEGLUROMET?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

African Regional IP Organization (ARIPO)

Australia

Canada

Costa Rica

Croatia

Cyprus

Denmark

Ecuador

Eurasian Patent Organization

European Patent Office

Georgia, Republic of

Japan

Montenegro

New Zealand

Poland

Portugal

Serbia

Slovenia

South Africa

South Korea

Spain

Ukraine

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering SEGLUROMET around the world.

Country	Patent Number	Title	Estimated Expiration
China	103497199	Dioxa-bicyclo[3.2.1]octane-2, 3, 4-triol derivatives
South Africa	201203486	DIOXA-BICYCLO[3.2.1]OCTANE-2,3,4-TRIOL DERIVATIVES
Japan	5696156

Supplementary Protection Certificates for SEGLUROMET

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2334687	C02334687/01	Switzerland		FORMER OWNER: PFIZER INC., US
2334687	2018/028	Ireland		PRODUCT NAME: ERTUGLIFLOZIN, OPTIONALLY AS A CRYSTAL FORM, PARTICULARLY AS A CO-CRYSTAL WITH L-PYROGLUTAMIC ACID, AND SPECIFICALLY AS ERTUGLIFLOZIN L-PYROGLUTAMIC ACID; REGISTRATION NO/DATE: EU/1/18/1267/001 EU/1/18/1267/012 20180321
2334687	2018C/027	Belgium		PRODUCT NAME: ERTUGLIFLOZINE, DESGEWENST IN KRISTALVORM, MET NAME ALS CO-KRISTAL MET L-PYROGLUTAMINEZUUR, EN SPECIFIEK ALS ERTUGLIFLOZIN L-PYROGLUTAMINE ZUUR; AUTHORISATION NUMBER AND DATE: EU/1/18/1267 20180323

SEGLUROMET Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for SEGLUROMET

Introduction

SEGLUROMET, a combination drug containing ertugliflozin (STEGLATRO) and metformin, has been a significant player in the treatment of type 2 diabetes. Here, we delve into the market dynamics and financial trajectory of this medication.

Market Context: SGLT-2 Inhibitors

SEGLUROMET is part of the SGLT-2 (sodium glucose co-transporter-2) inhibitor class, which has seen rapid growth due to its oral route of administration, strong HbA1c efficacy, weight reduction, and antihypertensive effects. This class includes other notable drugs like Invokana (canagliflozin), Jardiance (empagliflozin), and Farxiga (dapagliflozin)[1].

Market Entry and Approval

SEGLUROMET, along with its components STEGLATRO and fixed-dose combinations, received U.S. approval in 2017 and EU approval in March 2018. This timely approval positioned it well within a growing market[1][4].

Competitive Landscape

The SGLT-2 inhibitor market is highly competitive, with several key players. At the time of SEGLUROMET's market entry, Invokana was the market leader, but Farxiga and Jardiance were quickly gaining ground. SEGLUROMET's entry added another strong contender to this crowded market[1].

Cardiovascular Benefits

A crucial factor in the market success of SGLT-2 inhibitors is their cardiovascular benefits. Jardiance was the first to demonstrate these benefits in the EMPA-REG OUTCOME trial. SEGLUROMET's cardiovascular outcomes study (VERTIS CV) was ongoing, with results expected in 2019, which was essential for consolidating its market position[1].

Sales Projections and Performance

According to the 2018 Drugs to Watch report by Clarivate Analytics, SEGLUROMET was predicted to achieve significant sales. By 2022, Farxiga was forecasted to lead the market, followed by Jardiance, Zynquista, SEGLUROMET, and then Invokana. SEGLUROMET's projected sales for 2022 were around $1.275 billion, indicating a strong financial trajectory[1].

Real-World Evidence and Patient Impact

Real-world evidence suggests that SGLT-2 inhibitors, including SEGLUROMET, can significantly decrease heart failure hospitalizations and deaths. This supports their use earlier in treatment, potentially expanding the patient base and contributing to higher sales[1].

Side Effects and Safety Considerations

While SEGLUROMET offers several benefits, it also comes with notable side effects and safety considerations. These include the risk of diabetic ketoacidosis, acute kidney injury, urinary tract infections, and necrotizing fasciitis of the perineum (Fournier’s Gangrene). These risks necessitate careful patient selection and monitoring[2][4].

Regulatory and Clinical Recommendations

The European Medicines Agency and other regulatory bodies have outlined specific recommendations and precautions for the use of SEGLUROMET. It must not be used in patients with uncontrolled diabetes, severe kidney problems, or certain heart, circulatory, breathing, or liver problems. Continuous monitoring of side effects and necessary actions to protect patients are also emphasized[4].

Financial Impact on the Pharmaceutical Industry

The success of SEGLUROMET and other SGLT-2 inhibitors has significantly impacted the pharmaceutical industry's financial landscape. The rapid rise in sales of this drug class has contributed to substantial revenue for companies like Pfizer and Merck. The projected sales figures for these drugs indicate a continued financial growth trajectory for the companies involved[1].

Market Growth Drivers

Several factors drive the market growth of SEGLUROMET and other SGLT-2 inhibitors:

• Efficacy and Convenience: Strong HbA1c efficacy and the convenience of oral administration.
• Cardiovascular Benefits: Demonstrated reduction in cardiovascular complications.
• Weight Reduction: Additional benefit of weight loss.
• Real-World Evidence: Positive outcomes in reducing heart failure hospitalizations and deaths[1].

Challenges and Future Outlook

Despite the positive market dynamics, SEGLUROMET faces challenges such as competition from established brands and the need to manage and mitigate its side effects. However, with ongoing studies and real-world evidence supporting its benefits, SEGLUROMET is poised to continue its strong financial trajectory.

Key Takeaways

• SEGLUROMET is a significant player in the SGLT-2 inhibitor market.
• It has received U.S. and EU approvals and is projected to achieve substantial sales.
• Cardiovascular benefits and real-world evidence support its use.
• The drug comes with specific side effects and safety considerations.
• Regulatory recommendations and continuous monitoring are crucial.
• SEGLUROMET contributes to the financial growth of the pharmaceutical industry.

FAQs

What is SEGLUROMET used for?

SEGLUROMET is used to treat adults with type 2 diabetes, either alone or in combination with other diabetes medicines, along with diet and exercise[4].

What are the active ingredients in SEGLUROMET?

The active ingredients in SEGLUROMET are ertugliflozin (STEGLATRO) and metformin hydrochloride[4].

What are the common side effects of SEGLUROMET?

Common side effects include fungal infections of the vagina, urinary tract infections, and gastrointestinal problems such as nausea, vomiting, and abdominal pain[4].

Can SEGLUROMET be used in patients with type 1 diabetes?

No, SEGLUROMET is not indicated for glycemic control in patients with type 1 diabetes mellitus[2].

What are the cardiovascular benefits of SEGLUROMET?

SEGLUROMET, like other SGLT-2 inhibitors, may reduce the risk of heart failure and has ongoing studies to confirm its cardiovascular benefits[1].

Sources

1. Clarivate Analytics: Pfizer and Merck’s Steglatro for type 2 diabetes: a valuable addition to the rapidly rising SGLT-2 inhibitor market.
2. Merck.com: SEGLUROMET® (ertugliflozin and metformin hydrochloride) tablets, for oral use.
3. Oregon Drug Use Review / Pharmacy & Therapeutics Committee: Patterns of changes in bipolar depressive symptoms revealed by trajectory analysis among patients with bipolar disorder.
4. European Medicines Agency: Segluromet.